A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

Overview

The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.

Full Title of Study: “Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2006

Interventions

  • Drug: sibutramine hydochloride monohydrate
    • 10 mg QD with the option to increase dose to 15 mg QD up until Week 4

Arms, Groups and Cohorts

  • Experimental: 1

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss
    • Time Frame: 48 weeks
  • Safety parameters
    • Time Frame: 48 weeks

Secondary Measures

  • Waist and hip circumference
    • Time Frame: 48 weeks
  • Fasting glucose
    • Time Frame: 48 weeks
  • Fasting lipids
    • Time Frame: 48 weeks
  • Uric acid
    • Time Frame: 48 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has nutritional obesity and BMI >30 kg/m Exclusion Criteria:

  • Type 1 or type 2 diabetes mellitus – Inadequately controlled hypertension – History of Gilles de la Tourette's Syndrome. – Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids – Hypothyroidism or hyperthyroidism. – History of: – benign prostatic hyperplasia – neurological disorders – psychiatric illness – severe renal or hepatic impairments – narrow-angle glaucoma – History of cardiovascular disease or cerebrovascular disease – Persistent tachycardia at rest – Pulmonary hypertension – Phaeochromocytoma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Peter Bacher, MD, PhD, Abbott
  • Overall Official(s)
    • Global Medical Information 1-800-633-9110, Study Director, Abbott

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